Contract Pharmacal Corp.
Form 483 issued April 14, 2022 · Hauppauge, New York
- Inspection
- Apr 6 – Apr 14, 2022
- Observations
- 2
- Pages
- 3
- FEI number
- 2427358
In short: On April 14, 2022, FDA issued a Form 483 with 2 observations to Contract Pharmacal Corp. in Hauppauge, New York (FEI 2427358) after an inspection that ran Apr 6 – Apr 14, 2022. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in…
This inspection in context
Questions about this 483
What did FDA find at Contract Pharmacal Corp.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Contract Pharmacal Corp. inspected by FDA?
The inspection ran Apr 6 – Apr 14, 2022, and the Form 483 is dated April 14, 2022.
How do I get the full Form 483 for Contract Pharmacal Corp.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.