Johnson Matthey Inc.
Form 483 issued August 27, 2015 · Conshohocken, Pennsylvania
- Inspection
- Aug 17 – Aug 27, 2015
- Investigator
- Gayle S. Lawson
- Observations
- 6
- Pages
- 3
- FEI number
- 1000121320
In short: On August 27, 2015, FDA issued a Form 483 with 6 observations to Johnson Matthey Inc. in Conshohocken, Pennsylvania (FEI 1000121320) after an inspection that ran Aug 17 – Aug 27, 2015. The investigator was Gayle S. Lawson. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.22 (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 of APis and Intermediates is not…
- 02
The Quality Unit does not have…
- 03
Investigations of unexplained discrepancies and/or deviations are not always…
- 04
The firm does not have a documented system for managing quality that includes the participation of…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJohnson Matthey Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Johnson Matthey Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Johnson Matthey Inc.?
Gayle S. Lawson is named on this Form 483, for the inspection of Aug 17 – Aug 27, 2015. Each investigator has a profile showing what they cite most.
When was Johnson Matthey Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 27, 2015, and the Form 483 is dated August 27, 2015.
How do I get the full Form 483 for Johnson Matthey 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.