Site records / India / FEI 3003053502
Unique Pharmaceutical LaboratoriesBharuch
FDA-registered drug establishment in Bharuch: analysis, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- Oct 2022 · VAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0 of 4 under the name
- US border refusals, 2 years
- 0
This site, graded.
Every fact sourced.
- A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
- Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
- Warning-letter violations, numbered and labelled
- Import-alert history rebuilt from the archive, each listing checked against this address
- Border refusals by product, and the company's other sites, each graded
- A hash of every source read, so the PDF can be checked against the record
On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.
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Inspections
6 FDA inspections of this FEI, by end date; 6 with a posted classification.
- 23 Oct 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 7 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted
- 24 Aug 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
- 24 Jun 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 18 Oct 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 2 Dec 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
No FDA compliance action recorded against this FEI or letter to its name.
Import alerts in force
Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.
- 25 Aug 2017Import alert 66-41 · Published address cannot be tied to one site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 1 Plot No 21 , Road No , New Delhi, Delhi INDIA
- 10 Mar 2017Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA
- 10 Mar 2017Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA
- 28 Jun 2013Import alert 66-40 · Published address is not this site SourcePublished address: Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA
Other registered sites of JB Chemicals & Pharmaceuticals
- Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.)G.I.D.C Industrial Area Panoli, Gujarat
- Unique Pharmaceutical LaboratoriesBharuch
Registration
- FEI
- 3003053502
- DUNS
- 650434645
- Registered as
- Unique Pharmaceutical Laboratories
- Registrant
- Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)
- Address
- Plot No. 215-219, G.I.D.C Industrial Area, Bharuch, 394116, India (IND)
- Operations
- ANALYSIS, MANUFACTURE, PACK
- Registration expires
- 31 Dec 2026
Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.