The only good part of receiving an FDA warning letter is when a company gets a closeout letter that says it has finally met FDA expectations. It has taken three years, but generics maker CorePharma says it has gotten its closeout for a plant in New Jersey.
In a statement, the Middlesex, NJ, company took the positive approach, saying the "corrective actions provide a strong operational foundation" for its business. It said the letter, which has not yet been posted on the FDA website, was issued May 3.
CorePharma CEO Stephen White said, "This is a significant achievement by CorePharma and and is the result of a major commitment by our entire team to ensure compliance in a sustainable fashion. We look forward to continuing to serve our customers and growing our business while at all times adhering to the corrective actions we now have in place."
The warning letter for the company's Middlesex plant had criticized CorePharma for, among other things, releasing a batch of benzphetamine HCI tablets that had failed to meet the limits for coating defects. It was also taken to task for not getting to the root cause of why the thickness of some pilocarpine HCI tablets was out of spec and then releasing those as well. The company had also not figured out the cause of "small black spots" that turned up on 28 of 100 pyridostigmine bromide tablets during a random check by an operator.
- here's the release
- read the warning letter