Mac-chem products (india) Private Limited
Form 483 issued April 6, 2018 · Thane, India
- Inspection
- Apr 2 – Apr 6, 2018
- Observations
- 2
- Pages
- 2
- FEI number
- 3008799758
In short: On April 6, 2018, FDA issued a Form 483 with 2 observations to Mac-chem products (india) Private Limited in Thane, Maharashtra (FEI 3008799758) after an inspection that ran Apr 2 – Apr 6, 2018. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production System Changes to the API manufacturing process have not been…
- 02
Materials System Monitoring of the USP (6) (4) system did not include complete evaluation of test…
This inspection in context
Questions about this 483
What did FDA find at Mac-chem products (india) Private Limited?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Mac-chem products (india) Private Limited inspected by FDA?
The inspection ran Apr 2 – Apr 6, 2018, and the Form 483 is dated April 6, 2018.
How do I get the full Form 483 for Mac-chem products (india) Private 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.