Indoco Remedies Limited
Form 483 issued January 19, 2018 · Vasco Da Gama, India
- Inspection
- Jan 15 – Jan 19, 2018
- Investigator
- Cheryl Clausen
- Observations
- 1
- Pages
- 7
- FEI number
- 3006644152
In short: On January 19, 2018, FDA issued a Form 483 with 1 observation to Indoco Remedies Limited in Vasco Da Gama, India (FEI 3006644152) after an inspection that ran Jan 15 – Jan 19, 2018. The investigator was Cheryl Clausen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmIndoco Remedies Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Indoco Remedies Limited?
Cheryl Clausen is named on this Form 483, for the inspection of Jan 15 – Jan 19, 2018. Each investigator has a profile showing what they cite most.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Jan 15 – Jan 19, 2018, and the Form 483 is dated January 19, 2018.
How do I get the full Form 483 for Indoco Remedies 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.