FDA Cites Pine Pharma Over Sterility, Quality Control

FDA has cited Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the company’s drug outsourcing facility in Tonawanda, NY, according to a just-released inspection report issued in mid-November.

The inspection identified significant deficiencies in the company’s handling of sterile drug products, including inadequate investigation of particulate contamination, failures in aseptic technique, insufficient employee training, and weak production controls. Pine Pharmaceuticals operates as a registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act.

The agency documented five major inspectional observations on FDA Form 483, signaling potential noncompliance with current good manufacturing practice requirements.

Particulate contamination and batch release concerns

FDA investigators found that Pine Pharmaceuticals failed to adequately investigate unexplained discrepancies and quality defects before releasing sterile drug products for distribution. In one case, the firm released a batch of vancomycin injections despite confirmed particulate contamination, according to the 483. A customer complaint investigation identified cellulose particles and unidentified translucent fibers in returned vials. FDA investigators noted that the company characterized the incident as rare and concluded the lot was “essentially free” of visible particulates based on retain samples, even though multiple defective units had been confirmed. The firm provided a replacement vial to the complainant but did not implement corrective or preventive actions and did not attempt to identify all foreign materials detected.

Aseptic technique failures

The inspection report documented repeated failures to follow procedures designed to prevent microbiological contamination during aseptic processing. Investigators observed operators resting their arms on non-sterile surfaces and then extending their sleeves into ISO-classified critical areas without sanitization during sterile drug repackaging. Video review of production activities also showed operators failing to sanitize hands, sleeves, tubing, and monitoring equipment before entering critical zones.

Training and qualification gaps

According to the inspection findings, Pine failed to ensure that employees performing manual visual inspections were adequately trained and qualified. The firm revised its visual inspection qualification procedures in 2025 but did not retroactively reassess or requalify inspectors who had been approved under earlier standards, the 483 said. FDA investigators determined that at least one inspector would not have met the new qualification criteria but continued performing inspections after the revised procedure took effect.

Production controls and yield calculations

The FDA also cited Pine for failing to accurately calculate actual yield and defect rates during visual inspection. The agency said the firm’s procedures excluded some rejected units from defect calculations, potentially understating the true rate of particulate and other visual defects in finished products.

Process validation deficiencies

In a separate observation, FDA investigators found that Pine Pharmaceuticals lacked validated mixing and processing procedures for certain ophthalmic products, including compounded tropicamide and phenylephrine solutions. The agency said critical parameters such as mixing speeds were not specified, documented, or validated, and the firm relied primarily on operator training rather than process validation to ensure product quality.