Quality Upset


Are you a 503B or Pharmaceutical Manufacturer regulated by USFDA or a 503A regulated by your State?

What do you do if/ when your API supplier is inspected by FDA, receives a 483, and warning letter?

Do you have a quality agreement in place that specifies notification of inspection results?

Do you have alternate qualified suppliers to turn to while this manufacturer addresses their quality concerns/ issues with FDA?

What if, your supplier issues a recall of their API? Can you track and trace where this API was used, distributed to, and if necessary issue a recall?

Could this happen to you???  Do you have a plan when/ if this happens?

Receipt of Adulterated Drugs

In a recent warning letter PCCA was cited by FDA that the facility received [redacted] from supplier [redacted] on July 30, 2018.  All products from supplier [redacted] were listed on an Import Alert 66-40.   In the warning letter the FDA expressed a concern that in the past, [FDA has] taken regulatory action against at least 23 of your other API suppliers for the manufacture of adulterated drugs under section 501 of the FD&C Act by either listing their drugs on import alert and/or issuing them warning letters. Drugs from multiple API suppliers used by PCCA were listed on an import alert…

Adulteration and Misbranding of Glycerin API

Additionally, PCCA repackages glycerin USP. However FDA compared the testing required in the identification section of the USP monograph for glycerin with PCCA analytical test results, which reference the USP method, and determined the testing for identity of glycerin conducted by PCCA was incomplete and therefore was not adequate to assure that your [PCCA’s]  glycerin conformed to the compendial standards of identity.

Misbranding Due to False or Misleading Labeling of Drug Products

The labels your firm affixed to the following repackaged/relabeled API identify PCCA, but do not designate your firm’s role:

• tramadol HCl (lot # C191954);
• fentanyl citrate (lot # C189348);
• buprenorphine HCl (lot # C191213); and,
• morphine sulfate (lot # C192769).

Evidence collected during the inspection of your facility establishes that other firms were involved in the manufacturing of these API. Because these API labels bear only the PCCA name without further qualifications, the labels falsely represent that PCCA is the sole drug manufacturer.