The agency said Pfizer’s manufacturing of sterile injectable drugs at the plant was “out of control” and posed a risk to patient safety, according to a warning letter sent to the drugmaker Feb. 14 and made public Tuesday.
The FDA identified several drug products produced at the plant that were contaminated with foreign particulates and said the injectable antibiotic vancomycin was compromised by cardboard pieces, according to Reuters.
The presence of foreign particulates in Pfizer’s products represents “a significant loss of control in [its] manufacturing process and represents a severe risk of harm to patients,” the FDA wrote in the letter.
The agency clarified the manufacturing issues highlighted in the letter do not pertain to products currently on the market that were made at the site.
Pfizer said in a statement it’s “diligently implementing commitments made to the FDA” to address the agency’s concerns, reports Reuters.
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