923718

Nutronix Revolution, Inc. — FEI 3005984610

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 1, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Mechanicsville, VA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
113421 CFR 211.25(b)Supervisor Training/Education/Experience
136121 CFR 211.100(a)Absence of Written Procedures
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
149521 CFR 211.122(a)Written procedures describing in detail
1540421 CFR 111.12(c)Personnel - education, training, experience
1540921 CFR 111.14(b)(1)Personnel - records - written procedures
1545321 CFR 111.16Written procedures - cleaning
1549121 CFR 111.25Equipment - procedures
1553521 CFR 111.255(d)Batch record - 1 year, 2 years
1557321 CFR 111.153Written procedures - product received; packaging, labeling
1557821 CFR 111.155(c)Components - quarantine
1560621 CFR 111.165(c)(1)Product received - quarantine; representative samples
1564121 CFR 111.453Written procedures - holding
1564221 CFR 111.455(a)Hold - temperature, humidity, light
1566521 CFR 111.303Written procedures - tests, examinations; specifications met
1573621 CFR 111.353Manufacturing operations - written procedures
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1579021 CFR 111.403Written procedures - labeling operations
1579121 CFR 111.403Written procedures -packaging operations
1579721 CFR 111.553Written procedures - product complaint
1581921 CFR 111.55Production, process controls - implement
1586921 CFR 111.75(c)Specifications met - verify; finished batch
1589721 CFR 111.83(a)Reserve sample - collect, hold
1592721 CFR 111.103Written procedures - quality control operations
1601321 CFR 111.140(b)(1)Records - quality control operations; responsibilities
1604021 CFR 111.610(a)Records - available; FDA
1604621 CFR 111.503Written procedures returned dietary supplement investigation
189021 CFR 211.165(e)Test methods
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
230221 CFR 820.20(e)Quality System Procedures
241921 CFR 211.198(a)Complaint Handling Procedure
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
433821 CFR 211.150(b)Recall facilitation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures