Pharmaceutics International, Inc.
Form 483 issued July 10, 2020 · Cockeysville, Maryland
- Inspection
- Jul 6 – Jul 10, 2020
- Investigators
- Edmund F. Mrak· Robert J. Martin
- Observations
- 5
- Pages
- 6
- FEI number
- 3006503102
In short: On July 10, 2020, FDA issued a Form 483 with 5 observations to Pharmaceutics International, Inc. in Cockeysville, Maryland (FEI 3006503102) after an inspection that ran Jul 6 – Jul 10, 2020. The investigators were Edmund F. Mrak and Robert J. Martin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 03
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmPharmaceutics International, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International, Inc.?
Edmund F. Mrak and Robert J. Martin are named on this Form 483, for the inspection of Jul 6 – Jul 10, 2020. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International, Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 10, 2020, and the Form 483 is dated July 10, 2020.
How do I get the full Form 483 for Pharmaceutics International, Inc.?
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.