Pharmaceutics International Inc
Form 483 issued November 16, 2017 · Hunt Valley, Maryland
- Inspection
- Nov 6 – Nov 16, 2017
- Investigators
- James M. Mason· Ko U. Min· Marcus A. Ray
- Observations
- 10
- Pages
- 16
- FEI number
- 1000513101
In short: On November 16, 2017, FDA issued a Form 483 with 10 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Nov 6 – Nov 16, 2017. The investigators were James M. Mason, Ko U. Min and Marcus A. Ray. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
6 of 10 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (4×) · 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmPharmaceutics International Inc history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmaceutics International Inc?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
James M. Mason, Ko U. Min and Marcus A. Ray are named on this Form 483, for the inspection of Nov 6 – Nov 16, 2017. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Nov 6 – Nov 16, 2017, and the Form 483 is dated November 16, 2017.
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.