Week of May 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement included five warning letters to either homeopathic or OTC firms continuing the FDA’s focus in this area that we saw begin in 2017 and really ramp up in 2018.  Fundamental GMPs seem to be missing.  It appears that FDA has implemented enforcement against both the product owner and the contract manufacturer in this group.  This, in my opinion, is the only way that non-compliant contract manufacturing operations will be curtailed. If there are no consequences for the product owner, the behaviors will continue.

 

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DRUG, HOMEOPATHIC | Fill It Pack It Inc

Fill It Pack It Inc (Compton, CA) received a warning letter on May 2, 2019 based on the outcome of an inspection ending November 5, 2018.  FDA collected drug samples and upon testing found they were contaminated with Bacillus spp., high levels of particulate matter or both; the product owner recalled all lots after FDA contacted them.

The firm is a contract manufacturer for homeopathic ophthalmic drug products.  FDA reminds them of their responsibilities as a contract manufacturer and also suggested they employ qualified GMP consultants to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The firm does not have adequate controls in place to ensure that the multi-dose, preservative-free ophthalmic products they manufacture are sterile.  The facility itself did not have adequate architectural surfaces, lacks HEPA filtered air, did not have an adequate EM program, did not have a system for cleaning and disinfection of rooms and did not have adequate equipment controls for use in aseptic conditions.
  • The Quality Unit released the ophthalmic drug products where sterility was not assured.  Containers and closures used in the manufacture of the drug were not sterile.  These were received from their client for who they manufacture but they did not ensure they were sterilized before use.  The firm also did not have adequate written procedures governing activities of the quality unit.  This is a repeat observation from August 2018.

DRUG, HOMEOPATHIC | Bershel Enterprises LLC dba WePackItAll

Bershel Enterprises LLC dba WePackItAll (Duarte, CA) received a warning letter on May 2, 2019 based on the outcome of an inspection ending November 1, 2018.  This warning letter and the previous one seem to be issued to the same ‘parent’ firm.

They are reminded of their responsibilities as a contract manufacturer and are encouraged to employ consultants to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The first deficiency identified is identical to the one in the previous warning letter.
  • The firm released drug product without adequate investigation into visible contaminants in the bulk drug product, but rather relied on permission from [redacted] to reblend the particles back into solution.  FDA took issue with the lack of adequate investigation.
  • The firm failed to conduct annual product review and has no procedure describing these reviews.

DRUG | Kadesh Inc.

Kadesh Inc. (Garden Grove, CA) received a warning letter on May 2, 2019 based on the outcome of an inspection ending November 7, 2018.

In a press release, FDA identifies the firm as one that manufacturers drugs labeled as homeopathic products.  From the content of the letter, it seems that one or both of the sites menionted above manufacture product under contract for Kadesh Inc.

Deficiencies include but are not limited to:

  • The quality unit does not have roles and responsibilities, and released product without being able to assure it’s sterility.
  • The firm provides inadequate oversight of their contract manufacturer.  “For example, your Vice President signed a waiver to (b)(4) that explicitly approved the contract manufacture of ophthalmic drugs ‘in a nonsterile room’.  When asked by our investigator during inspection if the bulk ophthalmic drug product is filled aseptically, the same Vice President said your firm is unsure because you rely on your contract manufacturers to do everything.”  Further, FDA goes on to remind them of their responsibilities as the product owner.
  • The firm released bulk ophthalmic drugs to their contractor for further processing without preparing batch production or control records.  Further, each significant step in the manufacture is not documented.
  • The firm did not establish time limits for any steps during the manufacture of all bulk drug products they produce.  The firm committed to establishing limits for each processing step but failed to provide supporting documentation for the CAPA.
  • FDA also cites the firm for misbranded homeopathic drugs and provides several examples.

DRUG | US Continental Marketing, Inc

US Continental Marketing, Inc (Corona, CA) received a waring letter on May 2, 2019 based on the outcome of an inspection ending October 30, 2018.  It seems that this firm also may contract with one or both of the first two firms listed above.

FDA tested products and found them contaminated with Bacillus spp., high levels of particulate matter or both.  Deficiencies are very similar to those issued to Kadesh Inc.

Deficiencies include but are not limited to:

  • The firm’s Quality Unit released product without assuring it’s sterility.  The contract firm manufactured their homeopathic ophthalmic drug product for their customer.  In the quality agreement, the firm who received this warning letter provided primary containers used in the manufacture of the drug product but did not ensure that the contracting firm had adequate sterilizing capability for these components.

DRUG | Petra Hygienic Systems Int Ltd

Petra Hygienic Systems Int Ltd (Ontario, Canada) receive a warning letter on May 7, 2019 based on the outcome of a facility inspection ending December 21, 2018.  The firm manufactures OTC products.

The firm was placed on import alert on March 25, 2019.  Inspections in 2012 and 2014 identified similar issues.

Deficiencies include but are not limited to:

  • The firm released their OTC products to the US market without conducting finished product testing per NF requirements, and the release specifications differ from those in the NF. 
  • The firm failed to test incoming components but rather relied on the results in the suppliers CoA without establishing the reliability of the supplier’s analyses though validation.  Further, they did not conduct an identity test.
  • The cleaning of equipment has not been validated.
  • The firm lacks SOPs for various functions including Quality Unit responsibilities, vendor audits, and CAPA.  They also don’t always follow their own procedures.  FDA states that the firm’s quality system is inadequate.

 

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