Satyadeeptha Pharmaceuticals Limited
Form 483 issued January 11, 2018 · Humnabad, India
- Inspection
- Jan 8 – Jan 11, 2018
- Investigator
- Cheryl Clausen
- Observations
- 13
- Pages
- 5
- FEI number
- 3013987923
In short: On January 11, 2018, FDA issued a Form 483 with 13 observations to Satyadeeptha Pharmaceuticals Limited in Humnabad, Karnataka (FEI 3013987923) after an inspection that ran Jan 8 – Jan 11, 2018. The investigator was Cheryl Clausen. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.188 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch production and control records are deficient in that they do not include documentation of…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
There are no written procedures for production and process controls designed to assure drug substances have…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods…
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 firmSatyadeeptha Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Satyadeeptha Pharmaceuticals Limited?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Satyadeeptha Pharmaceuticals Limited?
Cheryl Clausen is named on this Form 483, for the inspection of Jan 8 – Jan 11, 2018. Each investigator has a profile showing what they cite most.
When was Satyadeeptha Pharmaceuticals Limited inspected by FDA?
The inspection ran Jan 8 – Jan 11, 2018, and the Form 483 is dated January 11, 2018.
How do I get the full Form 483 for Satyadeeptha 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.