Calyx Chemicals & Pharmaceuticals Limited
Form 483 issued November 8, 2019 · Boisar, India
- Investigator
- Carrie A. Hughes
- Observations
- 4
- Pages
- 4
- FEI number
- 3003721861
In short: On November 8, 2019, FDA issued a Form 483 with 4 observations to Calyx Chemicals & Pharmaceuticals Limited in Boisar, Maharashtra (FEI 3003721861). The investigator was Carrie A. Hughes. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Laboratory controls and quality system account for 4 of 4 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
Failure of your quality unit to ensure that there is stability data to support retest or…
- 02
Failure of your quality unit to review and approve…
- 03
Failure of your quality unit to ensure that critical deviations…
- 04
Failure to have laboratory control records that include complete data derived from all laboratory tests conducted…
This inspection in context
Carrie A. Hughes
8 documents · 2017–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmCalyx Chemicals & Pharmaceuticals Limited 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 Calyx Chemicals & Pharmaceuticals Limited?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. 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 Calyx Chemicals & Pharmaceuticals Limited?
Carrie A. Hughes is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Calyx Chemicals & Pharmaceuticals Limited inspected by FDA?
This Form 483 is dated November 8, 2019.
How do I get the full Form 483 for Calyx Chemicals & Pharmaceuticals Limited?
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.